MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO SD WIRE LOOP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SUTURELASSO SD WIRE LOOP
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
The surgeon was using the swift stitch to pass a suture through the labrum of the hip.He made one pass and when he brought the instrument out of the trim it cannula, the teeth would not advance as the sheath had disconnected from the shaft of the swift stitch.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer-provided photo, which displays the ar-4068-05sd wire loop caught within the broken suturelasso.However, as the devices involved in the event were not returned for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: SUTURELASSO SD WIRE LOOP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13471392
• Report Number: 1220246-2022-04405
• Device Sequence Number: 19260726
• Product Code: LXH
• UDI-Device Identifier: 00888867031418
• UDI-Public: 00888867031418
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SUTURELASSO SD WIRE LOOP
• Device Catalogue Number: AR-4068-05SD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 07/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown